FDA.reportPublic FDA data

MAUDE MDR 5573330

MDR report key
5573330
Report number
1018233-2016-00465
Event key
0
Event type
3
Date of event
2016-03-22
Date received
2016-04-13
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
JANNA PARKS
Address
8195 INDUSTRIAL BLVD COVINGTON GA 30014 US
Phone
770-770-7707
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1I125 SEEDS IN MICK CARTRIDGESI125 SEEDS IN MICK CARTRIDGESBARD BRACHYTHERAPY, INC. -1424526KXK1251CCEFBBAP0003, BBAP0020R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12016-04-130

Event Narratives#

N

Patient 1

THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE, A SUPPLEMENTAL REPORT WILL BE FILED. THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BARD. SAMPLE NOT AVAILABLE.

D

Patient 1

IT WAS REPORTED THAT THE SEEDS HAD LOST 25% OF THEIR ACTIVITY. THE PROCEDURE HAD TO BE DELAYED AND THE PATIENT WAS SENT HOME. A NEW IMPLANTATION IS SCHEDULED FOR (B)(6) 2016).

N

Patient 1

THE SAMPLE WAS NOT RETURNED FOR EVALUATION. THE DEVICE HISTORY RECORD WAS REVIEWED AND FOUND NOTHING THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. ALL DOCUMENTATION RELATED TO ORDER FILLING ACTIVITIES WAS REVIEWED AND NO DISCREPANCIES WERE OBSERVED. THE SALES ORDERS INDICATED THE REQUESTED ACTIVITY WAS 0.43MCI WHEN THE ORDER WAS FILLED ON(B)(6) 2016. THE IMPLANT DATES WERE (B)(6) 2016, RESPECTIVELY. ALL DOCUMENTATION, INCLUDING THE 10% ASSAY CERTIFICATE, SUPPORTS THAT THE SEEDS WOULD BE AT THE REQUESTED ACTIVITY ON THE REQUESTED IMPLANT DATES. (B)(4).